Job Description
What Regulatory Affairs contributes to Cardinal Health Regulatory provides regulatory affairs and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. This function applies subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process consulting. Regulatory Affairs plans, coordinates and implement regulatory strategies for products that require government approval. This job family proactively identifies regulatory requirements and risks for products and develops plans for product development programs and regulatory submissions. This is a remote position, and the ideal candidate is located near Mansfield, MA or Waukegan, IL. Job Summary The Sr Regulatory Affairs Specialist will support the Medical Solutions Regulatory Affairs team by providing regulatory expertise across a diverse portfolio of medical devices. This could include support of change development projects, new product development, change assessment, domestic submissions, international submissions, commercial support, manufacturing support, compliance related activities, systems improvement, and other responsibilities aligned with global medical device regulations and the goals of the Medical Solutions business. Responsibilities Under direction of manager, support new and modified product development projects to establish and integrate regulatory strategy into project activities. Lead, under direction of manager, the preparation, submission, and maintenance of global product registrations with a focus on 510(k), EU Technical Documents, and International STEDs. Collaborate with internal Cardinal international regulatory departments to assess international registration requirements